Venus Remedies secures Malaysian PIC/S Certification for pre-filled syringe facility

Anupama Ghosh Updated - November 05, 2024 at 10:43 AM.

The approval enables Venus Remedies to expedite regulatory approvals in other PIC/S member countries through mutual recognition agreements

Empty syringe in front of out of focus vial of medicine on metal tray. | Photo Credit: sshepard

Venus Remedies Limited has received Good Manufacturing Practices (GMP) approval with PIC/S accreditation from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) for its pre-filled syringe facility in Baddi, India. The certification, announced on November 5, 2024, marks the company’s first PIC/S GMP accreditation for its PFS facility.

The shares of Venus Remedies Limited were trading at ₹311.60 up by ₹1.70 or 0.55 per cent on the NSE today at 10.30 am.

The approval enables Venus Remedies to expedite regulatory approvals in other PIC/S member countries through mutual recognition agreements. The company’s robotic facility can produce over 20 million units of enoxaparin annually, an anticoagulant used to prevent and treat blood clots.

The certification process was completed within six months following an April 2024 audit. Venus Remedies currently holds marketing authorizations for enoxaparin in several markets, including Saudi Arabia, Azerbaijan, Philippines, and Myanmar.

The global enoxaparin market, valued at $3,315 million in 2023, is projected to reach $5,415 million by 2030, growing at a CAGR of 7.1 per cent. Venus Remedies, headquartered in Panchkula, operates in more than 80 countries and maintains nine manufacturing facilities globally, including locations in Panchkula, Baddi, and Werne, Germany.

Published on November 5, 2024 05:13

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